Roche: Class review a chance for successful Mircera launch

Roche has announced that an impending class review of renal anaemia agents will facilitate a strong launch for Mircera, a treatment for anaemia patients both on and not-on dialysis whose condition is associated with chronic renal failure.

The company reports that the compound has received a draft label for the compound from the US Food and Drug Administration, with the firm expecting this label to be finalised following a review of erythropoiesis stimulating agents (ESAs) in the renal setting.

Mircera is a chemically manufactured ESA that claims a longer half-life than other ESAs currently commercially available and has been the subject of phase II and phase III clinical studies involving 2,700 patients worldwide.

William M Burns, chief executive officer of the pharmaceutical division at Roche, said: “Today’s announcement is good news for us as it confirms our confidence in Mircera. We expect no further clinical trials being required prior to approval.”

He added that the class review would result in a market with more transparency that will enable a robust launch of the compound, with patients having improved assurances regarding the use of ESAs.

In November 2006, Roche reported positive results for Mircera in a phase III trial using epoetin alfa-beta or darbopetien alfa as comparator agents.